Ann Surg Treat Res.  2025 Feb;108(2):71-78. 10.4174/astr.2025.108.2.71.

The safety and anti-adhesive effect of acellular dermal matrix application after thyroid surgery: a multicenter randomized controlled trial

• Kim K
• Chai YJ
• Han M
• Kang SW
• Yun JS

• KMID: 2564245
• DOI: http://doi.org/10.4174/astr.2025.108.2.71

Abstract

Purpose
Postoperative adhesions following thyroid surgery can lead to multiple complications that significantly impact quality of life. The use of an acellular dermal matrix (ADM) adhesion barrier device has been proposed as a potential solution to reduce the risk of such adhesions. This study aimed to evaluate the safety and anti-adhesive effect of an ADM in patients undergoing thyroid surgery.
Methods
In this multicenter randomized controlled trial, patients undergoing thyroid surgery were randomly assigned to receive either ADM (n = 42) or no ADM (n = 39) during surgery. The primary outcome was the Swallowing Impairment Score (SIS-6), measured 6 weeks after surgery and compared between groups. Secondary outcomes included intergroup comparisons of the SIS-6, the Voice Handicap Index (VHI)-10, and the Glasgow-Edinburgh Throat Scale (GETS) at baseline, and 2, 6, and 18 weeks after surgery.
Results
At week 6, the mean SIS-6 scores were 4.0 ± 4.1 and 3.3 ± 4.2 in the ADM and control groups, respectively, which was not significantly different. Both groups showed similar postoperative improvements in SIS-6, VHI-10, and GETS scores over time, without significant differences between groups at any time point, indicating that the ADM did not reduce the incidence of postoperative adhesions or alter the course of recovery compared to the control group.
Conclusion
Although application of the ADM is safe for use in patients undergoing thyroid surgery, it did not produce a clinically significant advantage in preventing postoperative adhesions. Future research should focus on identifying specific patient populations or surgical scenarios where the use of the ADM may be beneficial.

Keyword

Randomized controlled trial; Safety; Thyroidectomy; Tissue adhesions

Figure

• 

  Fig. 1 Application of the acellular dermal matrix adhesion barrier device on the trachea during thyroid surgery.

• 

  Fig. 2 Application of the acellular dermal matrix adhesion barrier device between the subplatysmal flap area and strap muscles.

• 

  Fig. 3 Swallowing Impairment Score (SIS-6) in the acellular dermal matrix (ADM) and control groups over time.

• 

  Fig. 4 Voice Handicap Index (VHI)-10 scores in the acellular dermal matrix (ADM) and control groups over time.

• 

  Fig. 5 Glasgow-Edinburgh Throat Scale (GETS) scores in the acellular dermal matrix (ADM) and control groups over time.

Reference

1. Sarkar S, Banerjee S, Sarkar R, Sikder B. A review on the history of ‘thyroid surgery’. Indian J Surg. 2016; 78:32–36. PMID: 27186037.

2. Alci E, Kim SY, Yun HJ, Gozener S, Ozdemir M, Turk Y, et al. Evaluation of public’s perception of scar cosmesis after thyroidectomy: results of a survey of Turkish versus South Korean individuals. Ann Surg Treat Res. 2023; 105:119–125. PMID: 37693291.

3. Fassas S, Mamidi I, Lee R, Pasick L, Benito DA, Thakkar P, et al. Postoperative complications after thyroidectomy: time course and incidence before discharge. J Surg Res. 2021; 260:210–219. PMID: 33360304.

4. Kwon H, Kim JK, Lim W, Moon BI, Paik NS. Increased risk of postoperative complications after total thyroidectomy with Graves’ disease. Head Neck. 2019; 41:281–285. PMID: 30537006.

5. Vaiman M, Nagibin A, Olevson J. Complications in primary and completed thyroidectomy. Surg Today. 2010; 40:114–118. PMID: 20107949.

6. Bansal C, Bhardwaj A, Rathi S, Agrahari A, Singh VP. Postoperative complications of thyroid surgery: a corroborative study with an overview of evolution of thyroid surgery. Int J Head Neck Surg. 2017; 6:149–154.

7. Hellebrekers BW, Kooistra T. Pathogenesis of postoperative adhesion formation. Br J Surg. 2011; 98:1503–1516. PMID: 21877324.

8. Fatehi Hassanabad A, Zarzycki AN, Jeon K, Deniset JF, Fedak PW. Post-operative adhesions: a comprehensive review of mechanisms. Biomedicines. 2021; 9:867. PMID: 34440071.

9. Kim YM, Kim SJ, Yi JW, Seong CY, Kim JK, Yu HW, et al. Postoperative adhesion after thyroid surgery. Korean J Endocr Surg. 2016; 16:94–99.

10. Kim DY, Kang SW, Kim DS, Shin JU, Chung WY, Park CS, et al. Preventive effect of human acellular dermal matrix on post-thyroidectomy scars and adhesions: a randomized, double-blinded, controlled trial. Dermatol Surg. 2015; 41:812–820. PMID: 26066615.

11. Ahn JH, Yoon SG, Yi JW, Kim SJ, Lee KE. Anti-adhesive effect and safety of a thermosensitive adhesion barrier (Mediclore) for thyroid surgery: a double-blinded randomized controlled trial. Ann Surg Treat Res. 2022; 102:313–322. PMID: 35800997.

12. Waldron MG, Judge C, Farina L, O’Shaughnessy A, O’Halloran M. Barrier materials for prevention of surgical adhesions: systematic review. BJS Open. 2022; 6:zrac075. PMID: 35661871.

13. Chung JH, Chung Y, Cha YJ, Park SY, Moon HS, Kim YT, et al. Anti-adhesion agent to prevent of post-operative adhesion and fibrosis after vasectomy: a study using a rat model. Transl Androl Urol. 2022; 11:1234–1244. PMID: 36217400.

14. Flutur IM, Păduraru DN, Bolocan A, Palcău AC, Ion D, Andronic O. Postsurgical adhesions: is there any prophylactic strategy really working? J Clin Med. 2023; 12:3931. PMID: 37373626.

15. Yu HW, Lee D, Lee K, Kim SJ, Chai YJ, Kim HC, et al. Effect of an anti-adhesion agent on vision-based assessment of cervical adhesions after thyroid surgery: randomized, placebo-controlled trial. Sci Rep. 2021; 11:19935. PMID: 34620907.

16. Lee YJ, Ryoo HJ, Shim HS. Prevention of postoperative adhesions after flexor tendon repair with acellular dermal matrix in Zones III, IV, and V of the hand: a randomized controlled (CONSORT-compliant) trial. Medicine (Baltimore). 2022; 101:e28630. PMID: 35060544.

17. Shim HS, Park KS, Kim SW. Preventing postoperative adhesions after hand tendon repair using acellular dermal matrix. J Wound Care. 2021; 30:890–895. PMID: 34747219.

18. Gierek M, Łabuś W, Kitala D, Lorek A, Ochała-Gierek G, Zagórska KM, et al. Human acellular dermal matrix in reconstructive surgery: a review. Biomedicines. 2022; 10:2870. PMID: 36359387.

19. Boháč M, Danišovič Ľ, Koller J, Dragúňová J, Varga I. What happens to an acellular dermal matrix after implantation in the human body?: a histological and electron microscopic study. Eur J Histochem. 2018; 62:2873. PMID: 29569868.

20. Mohammadyari F, Parvin S, Khorvash M, Amini A, Behzadi A, HajEbrahimi R, et al. Acellular dermal matrix in reconstructive surgery: applications, benefits, and cost. Front Transplant. 2023; 2:1133806. PMID: 38993878.

21. Mihalečko J, Boháč M, Danišovič Ľ, Koller J, Varga I, Kuniaková M. Acellular dermal matrix in plastic and reconstructive surgery. Physiol Res. 2022; 71(Suppl 1):S51–S57. PMID: 36592440.

22. Macadam SA, Lennox PA. Acellular dermal matrices: use in reconstructive and aesthetic breast surgery. Can J Plast Surg. 2012; 20:75–89. PMID: 23730154.

23. Ibrahim AM, Koolen PG, Ashraf AA, Kim K, Mureau MA, Lee BT, et al. Acellular dermal matrix in reconstructive breast surgery: survey of current practice among plastic surgeons. Plast Reconstr Surg Glob Open. 2015; 3:e381. PMID: 25973359.

24. Kim JK, Lee CR, Kang SW, Jeong JJ, Nam KH, Cho SR, et al. Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: a randomized, multicenter, double-blind, non-inferiority study. PLoS One. 2022; 17:e0273215. PMID: 36121791.

25. Fatehi Hassanabad A, Zarzycki AN, Jeon K, Dundas JA, Vasanthan V, Deniset JF, et al. Prevention of post-operative adhesions: a comprehensive review of present and emerging strategies. Biomolecules. 2021; 11:1027. PMID: 34356652.

26. Liao J, Li X, Fan Y. Prevention strategies of postoperative adhesion in soft tissues by applying biomaterials: Based on the mechanisms of occurrence and development of adhesions. Bioact Mater. 2023; 26:387–412. PMID: 36969107.

27. Bae DS, Woo JW, Paek SH, Kwon H, Chai YJ, Kim SJ, et al. Antiadhesive effect and safety of sodium hyaluronate-carboxymethyl cellulose membrane in thyroid surgery. J Korean Surg Soc. 2013; 85:199–204. PMID: 24266009.

28. Park WS, Chung YS, Lee KE, Kim HY, Choe JH, Koh SH, Youn YK. Anti-adhesive effect and safety of sodium hyaluronate and sodium carboxymethyl cellulose solution in thyroid surgery. Asian J Surg. 2010; 33:25–30. PMID: 20497879.